Study comparing nivolumab to ipilimumab in prevention of recurrence of melanoma after complete resection of stage IIIb/c or Stage IV melanoma

Phase 1

• Conditions: High risk, completely resected Stage IIIb/c and IV melanoma subjects.; MedDRA version: 21.1Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-002351-26-GR
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-08
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1070

Inclusion Criteria

-Man and woman, 15 years or older (in some countries, only subjects aged 18 years or older will be recruited)
-Completely removed melanoma by surgery performed within 12 weeks of randomization
-Stage IIIb/C or Stage IV before complete resection
-No previous anti-cancer treatment
-Adequate function of the blood, kidney, and liver

Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 870
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 190

Exclusion Criteria

-Ocular or uveal melanoma
-History of carcinomatosis meningitis
-History of auto-immune disease
-Previous non-melanoma cancers unless complete remission since 3 years
-Treatment directed against the resected melanoma that is administrated after the surgery
-Postive testing for hepatitis B, hepatitis C, or known HIV

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified